Umbiblical cord clamping, cutting, and blood collecting device and method

ABSTRACT

There is disclosed herein a device for clamping and cutting an umbilical cord so as to enable blood samples from the umbilical cord to be collected and/or tested. The device provides for the clamping of a severed end of an umbilical cord and the automatic ejection of that clamped end. The device also provides for the cutting of an umbilical cord without using excessive force regardless of the size of the umbilical cord. Additionally, the device provides for the valved use of vacuum tubes to collect umbilical cord blood samples. Furthermore, the device enables the measurement of blood values at the moment of cutting the umbilical cord. Finally, the device also provides for the protection of users and others from exposure to sharps and blood.

INTRODUCTION

This application is a continuation of application Ser. No. 009,020,filed Jan. 26, 1993 now U.S. Pat. No. 5,415,665, which application is acontinuation-in-part of application Ser. No. 672,535 entitled "CordCutter Sampler" filed Mar. 19, 1991, now U.S. Pat. No. 5,190,556.

The present invention relates to medical devices for clamping, cutting,and sampling vessels, in particular umbilical cords.

BACKGROUND

There are many difficulties encountered by physicians and nurses in theprocess of cutting an umbilical cord shortly after the moment of birth.These difficulties cannot be overcome easily by current technology.

Difficulties arise due to the fact that at the moment of birth there isa great deal of fluid present, including blood and amniotic fluid fromthe mother, making the physician's gloved hands slippery. The procedureof clamping and cutting an umbilical cord first calls for the placementof a small first clamp close to the newborn to stop the flow of blood inthe cord and to clamp off what will become a first severed end of thecord (the end of the cord connected to the infant). The combination ofthe small clamp size and the fluid on the physician's gloved handscreates difficulty in applying the first clamp. In some cases thephysician cannot adequately close the clamp around the cord forcing thetemporary use of a metal hemostat in its place. Replacing the hemostatwith a clamp requires placing the clamp on the cord and re-cutting thecord stump. This procedure is often done as late as the infant's arrivalin the nursery.

Next, a second clamp must be placed by the physician sufficiently distalto the first to allow a cut to be made between the first and secondclamps and to clamp off what will become a second severed end of thecord (the end of the cord connected to the placenta). Generally, thisprocedure is also made by the deliverer while balancing the neonate inone arm. This procedure often presents the same difficulties asdescribed above.

Additional difficulties are presented because the cord is engorged withblood at birth and when the cord is severed blood commonly spurts fromthe incision spattering the medical team with droplets. As aconsequence, it is routine practice for the medical staff to wearprotective eye wear during the process for the purpose of protectingthem from exposure to blood. However, sometimes these protectiveelements dangerously block the view of the wearer (who may be aphysician).

Routinely samples of blood from the cord are collected for chemical andbiological assay. Such assays may include testing to determine whetherthe newborn is subject to possible genetically transmitted diseases.Currently two alternative methods are used to collect cord bloodsamples. These methods include draining the blood from the cord segmentdirectly into an open vial or extracting the blood directly from thecord by using a syringe and needle.

The draining method requires holding an open ended sample vial below thesecond severed end of the cord (the end connected to the placenta) whilereleasing the clamp from that severed end and directing the blood flowfrom that severed end into the sample vial. In most cases the cordsegment must be hand "milked" by squeezing the cord such that the bloodin the segment flows toward the vial. This "milking" action causes theflow of many contaminants in addition to the desired blood into thevial. Such contaminants include the mother's vaginal blood, amnioticfluids and Wharton's gel, all of which may affect the testing of thecord blood sample. As the complexity and sensitivity of the genetictests increase, the absence of contamination in the sample becomes moreimportant.

The extracting method requires using a syringe and needle to remove theblood directly from the cord. The needle is used to puncture the cordand the syringe is used to collect a blood sample. Care must be taken toprevent inadvertent needle sticks (which can lead to blood exposure).The contents of the syringe must then be transferred into appropriatevials. This transfer requires further steps of manipulating needles andsyringes which create additional risks of blood exposure.

In addition, both of these blood collection methods leave contaminationfrom blood on the external portions of the vials making it difficult toapply or retrieve patient labels and increasing exposure to blood. Thus,there are many problems associated with the current methods ofcollecting blood samples from umbilical cords.

A device has been designed, fabricated and tested which provides a muchimproved method of collecting samples of blood from an umbilical cord.The purpose of this device is to provide: (1) simple one handed clampingof umbilical cords at birth, regardless of size; (2) cutting umbilicalcords; and (3) automatically delivering adequate samples ofuncontaminated cord blood suitable for current laboratory analysis toprotected containers with little or no exposure to inadvertent bloodsplash or to sharp objects.

Embodiments of the device have been assembled, sterilized, and tested byphysicians in cases of both vaginal and caesarian births. The deviceshave effectively collected samples of cord blood. Duplicate samples ofblood taken by conventional methods were tested as a control to assurethe integrity of the device. The clinical testing was performed undercontrolled conditions during the last quarter of 1991.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the preferred embodiment of an umbilicalcord clamping, cutting, and blood collecting device in an open position.

FIG. 2 is a perspective view of the device of FIG. 1 in a closedposition.

FIG. 3 is an exploded view of the device of FIG. 1 showing its variouscomponents.

FIG. 4A is an exploded front view of the cutting apparatus of the deviceof FIG. 1.

FIG. 4B is an exploded back view of the cutting apparatus of the deviceof FIG. 1.

FIG. 5A is a front view of the right wall of the first housing.

FIG. 5B is a rear view of the right wall of the first housing.

FIG. 6A is a plan view of the right face of the manifold.

FIG. 6B is a plan view of the left face of the manifold.

FIG. 6C is a cross section of the manifold taken along line 6C--6C inFIG. 6B.

FIG. 7A is a left elevation of the device showing the sealing mechanismand cutting mechanism in phantom before the cutting apparatus has beenengaged.

FIG. 7B is a left elevation of the device showing the sealing mechanismand cutting mechanism in phantom after the cutting apparatus has beenengaged.

FIG. 7C is a front elevation of the device showing the sealing mechanismand cutting mechanism in phantom before the cutting apparatus has beenengaged.

FIG. 8A is a front elevation of the device without the blood collectionapparatus showing an umbilical cord enclosed in the device and variousfeatures of the device in phantom.

FIG. 8B is an enlarged view of a portion of the device of FIG. 8A.

FIG. 8C is a front elevation of the device without the blood collectionapparatus showing the dynamics of the cord cutting mechanism and variousfeatures of the device in phantom.

FIG. 8D is an enlarged view of a portion of the device of FIG. 8C.

FIG. 8E is a front elevation of the device without the blood collectionapparatus showing the dynamics of the cord cutting and blood collectingmechanisms and various features of the device in phantom.

FIG. 8F is an enlarged view of a portion of the device of FIG. 8E.

FIG. 8G is a front elevation of the device without the blood collectionapparatus showing the dynamics of the blood collecting mechanism andvarious features of the device in phantom.

FIG. 8H is an enlarged view of a portion of the device of FIG. 8G.

FIG. 9 is a cross-sectional view of the first housing showing the rockerslot and pin slot.

FIG. 10A is a plan view of the second housing.

FIG. 10B is a left elevation of the second housing.

FIG. 11A is a side elevation of the bottom arm of the clamp.

FIG. 11B is a bottom elevation of the bottom arm of the clamp.

FIG. 11C is an enlarged view of a-portion of the bottom arm of the clampfrom FIG. 11B.

FIG. 11D is a side elevation of the top arm of the clamp.

FIG. 11E is an enlarged view of a portion of the top arm of the clampfrom FIG. 11C.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Turning now to the drawings, and FIGS. 1 and 2 in particular, apreferred embodiment of the umbilical cord clamping, cutting, and bloodcollecting device 10 comprises a holding mechanism fabricated as a"clamshell" housing defined by a first housing 12 and a second housing14 each having an inner surface 13 and an outer surface 15 (FIGS. 1-3).As shown in FIGS. 1-3, the first and second housings 12 and 14 alsoinclude a front side 84, a back side 85, a right side 86, and a leftside 87. The housings 12 and 14 are preferably made from injectionmolded plastic. The housings 12 and 14 are attached to each other by asimple and conventional hinge 140 (FIGS. 5A, 5B, 7A, 7B, and 10B) andhinge pin (not shown) arrangement along their respective back sides 85to thereby comprise a clamshell housing. A removable umbilical cordclamp 18 is attached between the housings 12 and 14 at their respectiveleft sides 87 (FIGS. 1 and 2). The first housing 12 includes a bloodcollection apparatus 22 attached to its right side 86 and a surgicalcutting apparatus 24 which is held in place by a safety lock 26 (FIGS. 1and 2).

Before proceeding with a detailed description of the structure of thedevice 10, a general discussion of its operation will be helpful. Thereare basically four steps in using the device 10. FIG. 1 shows the device10 in a ready to use state. FIG. 2 shows the device 10 after it has beenemployed; namely, the device 10 is fastened around an umbilical cord 16of a baby 20 (FIG. 2) so the inner surfaces 13 are in contact with theumbilical cord 16. Comparing FIGS. 1 and 2, the operation of the device10 comprises the steps of:

(1) positioning the first and second housings 12 and 14 of the device 10around an umbilical cord 16 so the clamp 18 is positioned toward thebaby 20;

(2) closing the first and second housings 12 and 14 around the umbilicalcord to clamp the clamp 18 onto the umbilical cord 16 to thereby stopthe flow of blood through the cord 16;

(3) positioning the safety lock 26 to release the cutting apparatus 24;and

(4) manipulating the cutting apparatus 24 by forcing it downward tothereby sever the umbilical cord 16 and release the clamp 18 (and baby20).

Upon cutting the umbilical cord 16, the clamp 18 automatically detachesfrom the housings 12 and 14 and remains clamped to the part of the cord16 which is attached to the infant 20 (FIG. 2). Immediately, uponsevering the cord 16, the blood collection apparatus 22 begins tocollect samples of cord blood (the dynamics of this process aredescribed below and demonstrated in FIGS. 8A-8H). At any time aftersevering the cord 16, the blood collection apparatus 22 can be removedfrom the device 10 and the collected blood samples can be analyzed ortested. As described below, when the blood collection apparatus 22 isremoved from the device 10, the cord 16 is further automatically clampedby a protector 28 (far right side of FIG. 3). Further clamping of thecord 16 by the protector 28 prevents blood from flowing from the part ofthe cord 16 which is attached to the placenta (not shown).

Thus, a simple four step method replaces the complicated, dangerous, andtime consuming current procedure of placing a first clamp on anumbilical cord, placing a second clamp on the cord, cutting the cordbetween the clamps, removing the second clamp, placing a vial below theend of the cord which is not clamped, draining and milking the cord tocollect the blood therein, and reapplying the clamp to the cord.

The device 10 is primarily constructed of inexpensive injection moldedplastic components. It can be manufactured at low costs and can,therefore, be economically discarded after use to thereby preclude thepossibility of transmitting diseases through re-use.

A preferred embodiment of the device 10 is shown in the drawings. Asnoted above, the device 10 includes a plastic umbilical clamp 18attached to the housings 12 and 14 at the left sides 87 (FIGS. 1-3). Theclamp 18 is preferably made from injection molded plastic. The clamp 18includes a top arm 30 and a bottom arm 32 (FIGS. 1-3 and 11A-E). The topand bottom arms 30 and 32 hingedly snap together via a hook 148 (FIGS.11D-E) and axle 150 (FIGS. 11A-B) arrangement to form the clamp 18(FIGS. 1-3). The top arm 30 of the clamp 18 is fixed onto the firsthousing 12 (FIG. 1) by means of a rocker 34 (FIGS. 1 and 3). The rocker34 is rotatably attached to the first housing 12 in a rocker slot 136(FIGS. 1-3, and 9) in the first housing 12 by means of a pin (not shown)which rests in a pin slot 138 (FIG. 9) in the first housing 12. Therocker 34 may rotate about the pin (not shown). The rocker 34 includesan indentation 152 (FIG. 3) which fits around and holds the top arm 30of the clamp 18. The rocker 34 is preferably made from stainless steel.

The bottom arm 32 of the clamp 18 is attached to the second housing 14(FIG. 1). As shown in FIGS. 2, 3, and 10A-B, the second housing 14includes a clamp slot 142 near the back wall 85 and a clamp bump 144near the front wall 84. As shown in FIGS. 11A and 11B, the bottom arm 32of the clamp 18 includes fingers 201 and 202. The clamp bump 144 couplesto the finger 201 and the clamp slot 142 couples to the finger 202.These couplings allow the bottom arm 32 of the clamp 18 to snap onto thesecond housing 14.

The clamp 18 and the device 10 are held open to an angle ofapproximately sixty degrees by two sets of detents whereby the device 10is ready for use (as shown in FIG. 1). One set of detents is located onthe clamp 18 and the other set of detents is located on the first andsecond housings 12 and 14. As shown in FIGS. 11B and 11C, the bottom arm32 of the clamp 18 includes a set of detent bumps 154 near the axle 150.In addition, as shown in FIG. 11E, the top arm 30 of the clamp 18includes a detent slot 156 on the hook 148 (an identical slot, notshown, is on the opposite side of the hook 148). When the clamp 18 isassembled (i.e. when the clamp hook 148 engages the clamp axle 150), thedetent bumps 154 may engage the detent slots 156. When the bumps 154 arecaught in the slots 156, the clamp 18 is held open to an angle ofapproximately sixty degrees.

In addition, as shown in FIG. 5A, the first housing 12 comprises adetent shelf 158 near the back wall 85 which includes an indentation160. Furthermore, as shown in FIGS. 10A-B, the second housing 14comprises a detent tab 162 near the back wall 85. When the housings 12and 14 are assembled together to form the device 10, the detent tab 162on the second housing 14 engages the detent shelf 158 and indentation160 of the first housing 12. When the tab 162 is caught in theindentation 160, the first and second housings 12 and 14 are held opento an angle of approximately sixty degrees.

As noted above, the device 10 includes a surgical cutting apparatus 24attached to the first housing 12 (FIGS. 1-3). As shown in FIGS. 3, 4A,and 4B, the cutting apparatus 24 comprises three main components: aslide 36, a gasket 38 which is attached to the slide 36, and a blade 40which is also attached to the slide 36. The cutting apparatus 24 ispositioned in a slot 42 formed in the first housing 12 (FIG. 3) andextends above the outer surface 15 of the first housing 12 (note FIG.1). The cutting apparatus 24 is prevented from moving downward throughthe slot 42 by a safety lock 26 which is also attached to the firsthousing 12 (FIGS. 1-3). The safety lock 26 has an integrally moldedlocking tip 44 and a finger grip 46 (FIG. 3). The locking tip 44 fitsinto a lock notch 48 (which is molded on the slide 36 (FIGS. 3, 4A, and4B)) when the slide 36 is in an up or open position (as in FIG. 1) tothereby hold the slide 36 and, therefore, the cutting apparatus 24 in anup position and prevent the cutting apparatus 24 from moving downwardthrough the slot 42. However, when the locking tip 44 is removed fromthe lock notch 48, the slide 36 and, therefore, the cutting apparatus 24are free to be shifted from an up position (FIG. 1) through the slot 42to a down or cutting position (FIG. 2).

The surgical cutting apparatus 24 includes a blade 40 which has acutting edge 50 (FIGS. 3, 4A, and 4B). The blade 40 is mounted onto theslide 36 with the cutting edge 50 extending beyond the slide 36 but isrecessed in the slot 42 of the first housing 12 when the cuttingapparatus 24 is in an up position (whereby the safety lock 26 may beengaged) so that the lower cutting edge 50 of the blade 36 is notexposed when the device is open (FIG. 1). This feature reduces orminimizes the danger of exposure of the cutting edge 50 when the device10 is in an open position (as in FIG. 1). The cutting edge 50 of theblade 40 severs the umbilical cord 16 when the cutting apparatus 24 isplaced in a down or cutting position (FIG. 2).

As described above, a rocker 34 holds the top arm 30 of the clamp 18onto the first housing 12 (FIG. 1). The rocker 34 includes a back foot52 (FIG. 3). The back foot 52 of the rocker 34 engages a shelf slot 54(which is molded on the slide 36 (FIGS. 3 and 4A)) when the slide 36 isin an up position (as in FIG. 1). The shelf slot 54 includes a ceiling56 and a floor 58 (FIG. 4A) which limit the movement of the back foot52. When the slide 36 is locked in an up position the back foot 52 iscaught in the shelf slot 54 which prevents the back foot 52 from movingand, therefore, prevents the rocker 34 from rotating. As explainedlater, the rotation of the rocker 34 is important in assisting therelease of the clamp 18 from the first and second housings 12 and 14.

As shown in FIG. 3, the blood collection apparatus 22 comprises threemain components: a protective sheath 60, a sheath cap 62, and a set ofblood collection tubes 64 (which include rubber stoppers 66). Theprotective sheath 60 snaps over the blood collection tubes 64 and locksto the sheath cap 62 to thereby enclose and protect the blood collectiontubes 64 and rubber stoppers 66 (FIG. 2). The rubber stoppers 66 includeapertures 68 (FIG. 3) which provide access to the blood collection tubes64. In addition, the sheath cap 62 includes openings 70 (FIGS. 2 and 3)which provide access to the apertures 68 in the rubber stoppers 66 ofthe blood collection tubes 64.

Turning to FIGS. 3, 5A and 5B, the first housing 12 includes a rightwall 86 which includes an outer face 88 (FIG. 5A) and an inner face 90(FIG. 5B). As shown in FIGS. 5A and 5B, the right wall 86 includescommunicating holes 72 which extend through the inner and outer faces 90and 88 and are coupled to each other by a molded channel 92 on the innerface 90 (FIG. 5B). As shown in FIG. 3, needles 74 are mounted in thecommunicating holes 72 and pass through the openings 70 in the sheathcap 62 and through the apertures 68 in the rubber stoppers 66 to therebyprovide a passageway through which a vacuum within the blood collectiontubes 64 may communicate to the communicating holes 72 and moldedchannel 92 of the first housing 12 (see FIG. 3).

The device 10 includes a manifold 76 (shown in FIGS. 3 and 6A-6C) whichadjoins the inner face 90 of the right wall 86 of the first housing 12(see FIG. 3). The manifold 76 comprises a first face 82 (FIGS. 6A-6C)and a second face 83 (FIGS. 3 and 6B-6C). As shown in FIGS. 6A-6C, themanifold first face 82 includes a manifold aperture 80 which extendsthrough to the manifold second face 83. The manifold second face 83includes a ball valve seat 94. The manifold 76 is attached to the device10 with the manifold aperture 80 positioned over the molded channel 92(FIG. 5B) of the inner face 90 and the communicating holes 72 of theright wall 86 of the first housing 12. Thus, the manifold first face 82adjoins the inner face 90 of the right wall 86.

The manifold 76 and right wall 86 communicate the vacuum available atthe communicating holes 72 and molded channel 92 (provided from theblood collection tubes 64 via the needles 74, as explained above) intothe manifold aperture 80. Furthermore, the manifold aperture 80communicates the vacuum to a ball valve seat 94. A ball 96 placed intothe valve seat 94 seals off the vacuum available at the valve seat 94and manifold aperture 80 (FIGS. 3-4B and 6B).

As shown in FIGS. 1 and 3, the device 10 includes a plurality of barbs98 molded to the inner surface 13 of the second housing 14 which hold anumbilical cord 16 in place on the device 10. In another preferredembodiment of the device 10, the barbs 98 are replaced with an abrasivesurface (not shown) on the inner surface(s) 13 of either the first orsecond housings 12 and 14 or both. In all cases, the barbs 98 or theabrasive surface(s) securely hold the umbilical cord 16 in the housings12 and 14 and help prevent its release. The inner surface 13 of thesecond housing 14 also includes a plurality of guide fingers 100 moldedthereto which hold the cord 16 in proper alignment on the device 10(FIGS. 1 and 3).

In addition, an upset anvil 102 is attached to the inner surface 13 ofthe second housing 14. The upset anvil 102 is made from a thin sheet offlexible material (an elastomer for example) and is held in place by asoft foam spring 104 (FIGS. 1 and 3). The upset anvil 102 is positionedon the inner surface 13 of the second housing 14 whereby the cuttingedge 50 of the cutting apparatus 24 engages the upset anvil 102 as thecutting apparatus 24 passes through the slot 42 of the first housing 12and into a cutting position for cutting the cord 16 (as in FIG. 2). Thedevice 10 includes gels 106 which are attached to the inner surfaces 13of the first and second housings 12 and 14 opposing each other (FIG. 3).The gels 106 are made of soft flexible conforming material (silicone gelfor example) which conform to match and fit around the circumference ofan umbilical cord 16 which is placed between them. The gel 106 of thesecond housing 14 is placed between the upset anvil 102 and the barbs 98(see FIG. 3). The gel 106 of the first housing 12 meets the gel 106 ofthe second housing 14 when the device 10 is placed in a closed position.

The protector 28 is movably mounted on the first housing 12 (at theright side 86) and positioned directly below the sheath cap 62 when theblood collection apparatus 22 is mounted on the device 10 (FIG. 3). Thesheath cap 62 limits the movement of the protector 28. When the bloodcollection apparatus 22 is removed from the device 10, an upset wall 128on the sheath cap 62 forces the protector 28 to rotate to a positionwhereby the protector 28 clamps off the blood flow from the cord 16 andblocks the exposed ends of the needles 74 (the needles 74 are exposeddue to the removal of the blood collection apparatus 22).

The manipulation and operation of the device 10 will now be described indetail. The device 10 is packaged in an open, ready to use, positionwhereby a physician (or other user) may grasp the device 10 with onehand. The device 10 includes two sets of detents (described above). Oneset is on the first and second housings 12 and 14 and the other is onthe clamp 18. The detents hold the device 10 open to an angle ofapproximately sixty degrees and prevent premature accidental closing ofthe device 10. When the baby 20 is delivered the user will support thebaby 20 with one hand while grasping the device 10 with the other. Thedevice 10 is placed around the umbilical cord 16 with an alignmentbumper 108 (FIGS. 1-3) molded on the left side 87 of the second housing14 is positioned toward the baby 20 (FIG. 2). The alignment bumper 108may be placed directly against the baby's stomach if desired, leaving acord protrusion from the baby 20 of about a half inch. It is notnecessary for the bumper 108 to touch the baby 20 and the device 10 maybe placed anywhere along the umbilical cord 16 as long as the bumper 108is positioned toward the baby 20 (FIG. 2). Once the device 10 is inposition, the user closes the first and second housings 12 and 14 towardeach other to thereby force a locking latch 110 which is molded on thefront side 84 of the first housing 12 (FIGS. 1-3 and 5A-5B) onto alocking latch receiver 112 which is molded on the front side 84 of thesecond housing 14 (FIGS. 1 and 3) to thereby lock the device 10 in aclosed position (FIG. 2).

When the device 10 is closed, the clamp 18 is also closed. As describedabove, the clamp 18 comprises a top arm 30 and a bottom arm 32 (FIGS.1-3). As shown in FIGS. 1 and 3, the top arm 30 of the clamp 18 includesa clamp latch 114 and the bottom arm 32 includes a clamp latch receiver115. When the device 10 is closed, the clamp latch 114 snaps into theclamp latch receiver 115 to thereby close the clamp 18 around theentrapped umbilical cord 16 whereby the cord 16 between the baby 20 andthe device 10 collapses and the blood flow is clamped off (FIG. 2).Although the clamp 18 is closed, it is held in place on the device 10 bythe rocker 52 which is supported by the floor 58 of the shelf slot 54 onthe slide 36 (FIG. 3). Meanwhile, the gels 106 in the first and secondhousings 12 and 14, are forced over and around the circumference of theentrapped cord 16 to thereby form a seal around the entire periphery ofthe cord 16 (FIG. 3). The gels 106 must be made of soft and conformingmaterial (e.g. silicone gel) to allow contact with all nooks andcrannies of all varieties of umbilical cords 16 and to thereby create aleak proof seal around an entrapped umbilical cord 16 while not undulyclamping the cord 16 or constraining the blood flow within the cord 16.

Once the device 10 is closed, the user may engage the finger grip 46with the thumb of the hand holding the device 10 and slide the safetylock 26 to thereby disengage the locking tip 44 from the lock notch 48to thereby free the cutting apparatus 24 (FIG. 3). The user's same thumbmay now depress the slide 36 of the cutting apparatus 24 forcing thecutting edge 50 of the blade 40 through the entrapped cord 16 and intothe upset anvil 102 (FIG. 3). The upset anvil 102, upon reaching itsbuckling load, collapses against the light force of the soft foam spring104 to thereby allow the cutting edge 50 to proceed toward the secondhousing 14 (FIG. 3). The upset anvil 102 is shown in FIG. 2 as itappears after the cutting action. This method of using a buckling upsetanvil 102 allows the blade 40 to move through the cord 16 and into softelastomer which buckles out of the way to thereby ensure a clean cut andallow a low cutting force.

While the blade 40 cuts through the cord 16 the shelf slot 54 of theslide 36 moves toward the second housing 14 (FIG. 3). The ceiling 56 ofthe shelf slot 54 engages the back foot 52 of the rocker 34 to therebyforce the rocker 34 to rotate and push the clamp 18 out of the device 10(FIG. 3). The rocker 34 is made of thin metal (preferably stainlesssteel) which is much harder than the top arm 30 of the clamp 18 (whichis made of soft injection molded plastic). The advantage of thismechanism is to allow a physical dimension to be set in reference to therocker 34 and the support of the bottom arm 32 of the clamp 18. Excesstolerance will be taken up by the rocker 34 penetrating into the top arm30 of the clamp 18. The physical dimensional control assures that theclamp 18 will lock when the device 10 is closed regardless of the sizeof the entrapped umbilical cord 16. The size of a human umbilical cord16 may vary from less than one third of an inch to slightly over an inchin diameter. Therefore, it is important to insure that a clamp 18 locksaround a variety of different sizes of umbilical cords 16.

As described above, the cutting apparatus 24 includes a gasket 38 whichis attached to the slide 36 (FIGS. 3 and 4A-4B). As shown in FIG. 4B,the gasket 38 includes a seal 120 which surrounds a gasket pocket 122and a blood flow channel 124. FIGS. 7A-7C and 8A-8H show the sealingmechanism of the device 10 in conjunction with the cutting mechanismdescribed above. As described above, the device 10 is used to entrap anumbilical cord 16 (FIGS. 8A-8B), sever the entrapped cord 16 (FIGS.8C-8F), and clamp and eject one severed end of the cord 16 to therebyrelease the baby 20 (FIG. 2). The other severed end of the cord 16comprises a cord opening 126 (FIGS. 7A-7B and 8E-8H) and is attached tothe placenta (not shown). The device 10 collects blood samples from thecord opening 126 of the cord 16 (FIGS. 2, 7A-7B, and 8E-8H).

As shown in FIG. 4B, the cutting apparatus 24 includes an upset pin 116which is molded to the slide 36 and protrudes out of an opening 118 inthe gasket 38 when the cutting apparatus 24 is assembled. The upset pin116 is an important feature of the device 10 with regard to collectingblood samples. As described above, the cutting apparatus 24 ismanipulated to sever a cord 16 by forcing the cutting apparatus 24downward into a cutting position (FIG. 2). As the cutting apparatus 24moves downward, the upset pin 116 also moves downward toward the secondhousing 14 and contacts a ball 96 (seated in the ball valve seat 94 inthe manifold 76) which is sealing off the vacuum from the bloodcollection tubes 64 (FIGS. 7A-7C and 8A-8H). The pin 116 contacts theball 96 at the precise time that the seal 120 completely surrounds thecord opening 126 (FIGS. 7A-7C and 8A-8H). As the slide 36 is pushed toits furthest downward position, the upset pin 116 moves the ball 96 outfrom the ball valve seat 94 (FIG. 7B) to thereby allow communication ofthe vacuum from the blood collection tubes 64 through the needles 74,the communicating holes 72 in the first housing 12, the manifold 76 (viathe manifold aperture 80), the ball valve seat 94, and the gasket pocket122 and blood flow channel 124 in the gasket 38 to the just cut face ofthe cord 16 which defines the cord opening 126 (see FIGS. 8G-8H). Theseal 120 is designed to enclose the cord opening 126 whereby the bloodin the cord 16 moves directly into the blood collection tubes 64 (viathe opened vacuum) as soon as the cord 16 is cut by the cutting edge 50of the blade 40 (see FIGS. 8G-8H).

FIGS. 8A-8H show the blood collection procedure in detail. FIGS. 8A and8B show the device 10 (without the blood collection apparatus 22) afteran umbilical cord 16 has been entrapped and the cutting apparatus 24 hasbeen released and is in position to cut the cord 16. The ball 96 ispositioned in the ball valve seat 94 (FIGS. 8A-8B) blocking off thevacuum from the blood collection apparatus 22 (not shown). FIGS. 8C and8D show the device 10 (without the blood collection apparatus 22) as theblade 40 of the cutting apparatus 24 cuts through the entrapped cord 16and meets the upset anvil 102. The ball 96 is still positioned in theball valve seat 94 (FIGS. 8C-8D). FIGS. 8E and 8F show the device 10(without the blood collection apparatus 22) after the blade 40 hasinitially cut through the cord 16 and the upset anvil 102 buckles out ofthe way. The seal 120 of the gasket 138 does not quite completelysurround the cord opening 126 formed when the cord 16 was cut and theblood flowing in the cord 16 has entered and filled the gasket pocket 22and blood flow channel 24 (FIGS. 8E-8F). The ball 96 is still positionedin the ball valve seat 94 (FIGS. 8E-8F). FIGS. 8G and 8H show the device10 (without the blood collection apparatus 22) after the cuttingapparatus 24 has been placed in a fully cut position, the upset anvil102 is fully-buckled, the seal 120 completely surrounds the cord opening126, and the upset pin 116 of the slide 36 has dislodged the ball 96 tothereby expose the blood in the gasket pocket 122 and blood flow channel124 to the vacuum available at the manifold aperture 80 from the bloodcollection tubes 64 (not shown). The vacuum from the blood collectiontubes 64 draws the blood through the manifold aperture 80, thecommunicating holes 72 in the first housing 12, the needles 74 and intothe tubes 64 (not shown).

Once the blood collection tubes 64 have been filled with cord 16 blood,the blood collection apparatus 22 may be removed from the device 10 bymerely pulling the apparatus 22 outward from the device 10 (FIG. 3). Asthe blood collection apparatus 22 is pulled from the device 10, an upsetwall 128 molded to the sheath cap 62 (which is removed with the bloodcollection apparatus 22) engages an escapement 130 molded on theprotector 28 to thereby force the protector 28 to rotate (clockwise inFIG. 3). As the protector 28 rotates, needle notches 132 (FIG. 3) aresnapped past and block the needles 74. Furthermore, a cord squeezer wall134 (FIG. 3) is rotated against and clamps off the cord 16 which isstill attached to the placenta to thereby clamp off any blood flow fromthe placenta. The pressure of the cord 16 on the cord squeezer wall 134stops clockwise movement of the protector 28 while pressure of theneedles 74 against the protector 28 prevents counterclockwise movement(FIG. 3). This positioning of the protector 28 clamps the cord 16 tothereby prevent further blood flow from the placenta (not shown) whilealso protecting medical personnel from puncture wounds by blocking theneedles 74.

The blood collection tubes 64 can be easily extracted from theprotective sheath 60 by a simple two step process: (1) the sheath cap 62is squeezed to thereby unlock the sheath cap 62 from the protectivesheath 60 and expose the blood collection tubes 64, and (2) the bloodcollection tubes 64 are removed from the protective sheath 60 (FIG. 3).The outside of the tubes 64 are free of contamination from blood flowexposure during the procedure which allows personnel to easily labeleach tube 64 with information (such as patient identification). Twoblood collection tubes 64 are preferably used so one may be pre-loadedwith the precise amount of anticoagulant needed for testing the bloodsample (FIG. 3). Other devices can be easily manufactured usingdifferent numbers and/or types of blood collection tubes 64 which arefilled with varying amounts and types of chemicals.

The present device 10 can also include, for little extra cost, a throughhole 200 on the left side 86 of the device 10 (see FIGS. 1-3 and 9), asimilar matching through hole 210 on the slide 36 (see FIGS. 3-4B), anda thin wall 220 molded into the gasket 38 (see FIGS. 3-4B). Thesefeatures enable certain on-the-spot analyses to be performed.

After the device has been clamped over an umbilical cord, and the cordhas been cut and blood sampled, a small volume of blood is left in theslot 124 of the gasket 38. The blood left in the slot 124 makes directcommunication with a thin wall 220 molded into the gasket 38 and locateddirectly behind the through hole 210 in the slide 36 (see FIGS. 3-4B). Aprobe (not shown) containing any of a number of electrode or opticalsensors can be placed through the holes 200 and 210 to make directcontact with the thin wall 220 which is wet on its other side with bloodin the slot 124. The probe may thereby make a measurement of the blood.For example, blood pH measurements are commonly made by placing a Clarkelectrode directly onto a thin wall membrane which separates the bloodto be tested from the sensor. Similarly, saturated oxygen measurementsmay be made by directing infra-red light emitted by a probe through thethin wall 220 and measuring reflected light. Thus, the additionalfeatures of through holes 200 and 210 and thin wall membrane 220 enableon-the-spot measurements of non-contaminated blood immediately at birth.

While a preferred embodiment of the present invention has been shown anddescribed, various modifications may be made without departing from thescope of the present invention, and all such modifications andequivalents are intended to be covered.

What is claimed is:
 1. Apparatus for cutting an umbilical cord andcollecting a blood sample therefrom, comprising:a housing enablingreceiving and entrapping a portion of umbilical cord; and a cuttermovably attached to said housing enabling cutting an umbilical cord anddirecting blood contained within the umbilical cord to a blood receiver;said housing holding said blood receiver and enabling fluidcommunication between the blood within the umbilical cord and the bloodreceiver whereby the blood receiver receives blood contained in theumbilical cord in a clean manner.
 2. The apparatus of claim 1 furthercomprising an anvil attached to the housing for facilitating the cutterin cutting the umbilical cord.
 3. The apparatus of claim 1 furthercomprising a safety lock attached to the housing for selectivelypreventing the cutter from moving.
 4. An umbilical cord clamping andcutting device comprising:a first housing and second housing movablyconnected together and movable to a closed position to entrap at least aportion of an umbilical cord; a cutter attached to the first housing andmovable from a disengaged position to an engaged position to thereby cutan entrapped umbilical cord; an anvil attached to the second housing toencounter the cutter when said cutter is moved to an engaged position; afirst gel on the first housing and a second gel on the second housingfor circumscribing the entrapped umbilical cord and thereby forming aseal around the cord and between the cord and the first housing andsecond housing; and a blood collector removably attached to the firsthousing for collecting blood from the umbilical cord.
 5. The device ofclaim 4 further comprising a safety lock attached to the first housingfor selectively preventing the cutter from moving.